chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feeling unwell; This is a spontaneous report from a contactable consumer or other non HCP.   A 65-years-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 17Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in Apr2021, the patient was feeling unwell and she tested for Covid today 21Apr2021. She is due for her second dose on 8May2021. Patient asking for what the recommendations were on receiving the second dose after testing positive for Covid.   No follow-up attempts are needed. No further information is expected.
Abscess on the liver; missed his second dose; Fever; A spontaneous report  was received from a consumer (patient's wife), regarding a 61 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced abscess on the liver (liver abscess), fever (pyrexia) and inappropriate schedule of product administration.    The patient's medical history was not reported. Concomitant medications was not reported.  On 13 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 19 Feb 2021, the patient developed fever and was hospitalized because of abscess on the liver. The patient was hospitalized for eight days and missed his second dose because doctors said that the patient was still weak to take the second vaccine dose. The patient was discharged on 27 Feb 2021. Treatment for the events included unspecified antibiotics.  Action taken with second dose of mRNA-1273 in response to the events was not reported.   The outcome of the events, abscess on the liver, and fever, were considered as unknown.  The event, inappropriate schedule of product administration, was considered recovered/resolved.; Reporter's Comments: Although a temporal association exist, and there is lack of patient's medical history and list of concomitant medications, based on the known risk and etiology of liver abscess, the events are assessed as unlikely related to mRNA-1273 administration.
he had both Shingrix vaccine/ Shingles episode on mid-May of this year 2021.; Shingles / shingles outbreak; an unusual very mild rash/rash was on the back-left side of the torso; itched/ itching at the left side of the face; pain on the left trigeminal nerve; Shingles nerve problems; still pain on the face; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In May 2021, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash, pruritus facial, trigeminal neuralgia, neurological disorder nos and facial pain. The patient was treated with gabapentin. On an unknown date, the outcome of the vaccination failure, rash, pruritus facial and trigeminal neuralgia were unknown and the outcome of the shingles was recovered/resolved and the outcome of the neurological disorder nos and facial pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash, pruritus facial, trigeminal neuralgia, neurological disorder nos and facial pain to be related to Shingrix and Shingrix.  Additional detaails were provided as follows: The reporter was the patient. The patient received both Shingrix shot as soon as the vaccine was available around 2017. The patient had the Zostavax vaccine before getting both doses of Shingrix. The patient had Shingles episode on mid-May of this year 2021. The reporter stated that, had an unusual very mild rash that he thought it was bug bites and it itched not painful. The patient reported the shingles rash was on the back-left side of the torso, itching at the left side of the face with pain on the trigeminal nerve, with no visible rash, only itching. The patient stated that the outbreak of the Shingles rash happened simultaneously at the same time the itching and pain on the left trigeminal nerve started. This trigeminal left nerve  was never an issue before. The patient reported, had been prescribed Gabapentin and will be starting a new anti-seizures medication. The reporter stated that, did not have Shingles now and only had shingles nerve problems and still pain on the face. The reporter stated that, no pain in the torso area. Not all information was available. Both dates of vaccination were unknown. Lot and expiration dates were unknown. The reporter consented to follow up.
In 12/01/06, child received Dtap, Hib, Prevnar and Hep A. Child had received all of these vaccines in past without problems. Within 24 hours of vaccines, child with screaming fits daily lasting 30 min to 1 hour and frequent night waking. Behavior continues child seen for issues on 12/29/06.
On the right side/arm where she got the Covid vaccine she has redness, tenderness, and swelling. When she came in we checked her temp is 100.4 and after a repeat it was 100.6.  Patient stated that the swelling has gone down but that it was a lot worse last night/early this morning. She went to her PCP around 8am this morning where they did lab work and the PCP told her to come back to the pharmacy clinic where she received it to get it checked out. We recommended icing the arm and resting. We gave her paperwork for precautions of what to watch for and when to go to the ER. Also advised to follow up with her PCP.
The event is as follows,: The patient is under age of 16 and was given the 1st Dose Moderna in as series of 2. doses. It was given by mistake a shot of Moderna Covid-19 Vaccine. The parent brought the child back for the 2nd dose and that is when the mistake was discovered.
Besides terrible Headache, fever chills, extreme weakness, fatigue lasting 15 hrs: I experienced facial swelling, especially around the left eye
Patient came in for their COVID shot. When the vial was retrieved from the refrigerator someone had accidentally switched the locations of the pediatric and adult COVID vaccines. Unfortunately due to a series of events this was not discovered until after shot was given. Upon discovery I called patient, explained what had occurred and they were understanding, agreeing to return to the pharmacy for revaccination with the correct dose as per guidance from leadership. The patient returned and was revaccinated with the correct dose on 3/19/22.
1-2min p/vax pt fainted & was out for 20second;eyes rolled upwards briefly, had blotchy rash w/circumoral pallor & abd pain;given med;
I am fine except these little red bumps come up; rash; red spots /blotches; This is a spontaneous report received from a contactable consumer (patient himself). An 89-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included cancer sores and History of cancer. The patient's concomitant medications were not reported. Patient previously took first dose of COVID-19 vaccine for COVID-19 immunization and he states that he has red spots/blotches on his ankles, hips, back and chest. The patient experienced fine except little red bumps come up on an unspecified date and was hospitalized. He also experienced rash on an unspecified date. Therapeutic measures for the rash included he had an unspecified cream two times a day. The outcome for the both the events was unknown.  Information about lot/batch number has been requested.
Dry Cough, nasal congestion, low grade fever and fatigue.  Concern about cough and nasal congestion.  Could this be due to vaccine?  No problem with smell or taste.
Instantaneous burning, chills, sweats- this occurred upon administration of the vaccine.   Subsequent symptoms which are ongoing are fever, body aches, bed  ridden, fatigue, increased heart rate, shortness of breath, nausea vomiting., increased blood pressure, pain dizziness, light headedness   So far still unable to work and mostly bed ridden.   Upon risk benefit assessment it was determined since I do not need oxygen or an IV, it?s better for me to remain at home since I have the equipment to monitor pulse ox levels, blood pressure and heart rate and with my immunity being so fragile right now- hospital setting is not the best environment. Discussion of hospitalization ongoing.   All Side effects still  unknown and ongoing.
On 12/15/2022 in the evening I started feeling bad. I felt weak and had no energy. I felt like I was getting the flu. On 12/16/2022 in the morning I was experiencing difficulty breathing. I had a temperature of 105, loss of appetite, headaches. I took TYLENOL to come the fever down. On Saturday I developed cough so, I took MUCINEX for cough. On Sunday 12/18/2022 I took a home COVID-19 test which was positive. On Monday 12/19/2022 I called my doctor's office they said my doctor won't be able to do telehealth for 2 days and they advised me to go to a different office which was 25 miles away from my house. I was so sick that I had no energy to drive there so I didn't go. On 12/24/2022 I took another COVID-19 test which was positive again. On 12/26/2022 I took another COVID-19 test which was positive. On 12/29/2022 I tested myself again with a home COVID-19 test this time it was negative. On 12/30/2022 and 12/31/2022 I tested negative for COVID-19. As of today I still experience difficulty breathing while doing daily activities.
Patient is feeling as she puts it very heavy after the 2nd dose; Patient's throat is tightening after the 2nd dose; Patient feels like she's dying after the 2nd dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION COMPLICATION (Patient is feeling as she puts it very heavy after the 2nd dose), THROAT TIGHTNESS (Patient's throat is tightening after the 2nd dose) and FEELING ABNORMAL (Patient feels like she's dying after the 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Patient is feeling as she puts it very heavy after the 2nd dose), THROAT TIGHTNESS (Patient's throat is tightening after the 2nd dose) and FEELING ABNORMAL (Patient feels like she's dying after the 2nd dose). At the time of the report, VACCINATION COMPLICATION (Patient is feeling as she puts it very heavy after the 2nd dose), THROAT TIGHTNESS (Patient's throat is tightening after the 2nd dose) and FEELING ABNORMAL (Patient feels like she's dying after the 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient received all vaccines without difficulty. Approximately 2 minutes after the last vaccine given, patient experienced a vasovagal reaction associated with an episodic tremor (lasted approximately 5 seconds). Patient did not lose consciousness. Patient was placed in a comfortable position, given juice, and observed for 30 minutes. Symptoms improved and patient was picked up from the the health center by parent (mother).
Redness, swelling and itching of affected right arm. Mother reports redness and swelling decreased significantly by report date of 1/9/12.
breakthrough infection; breakthrough infection; This is a literature report for the following literature source(s).  A 59-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Kidney transplant" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), BREAKTHROUGH COVID-19 (medically significant), all with latency 13 days after the suspect product(s) administration, outcome "unknown" and all described as "breakthrough infection". Breakthrough infection noted 13 days post-vaccination of dose 3. The patient underwent the following laboratory tests and procedures: Antibody test: 30.5 IU/ml, notes: Pre-exposure; 227 IU/ml, notes: Original post-exposure; 163120 IU/ml, notes: Retested post-exposure.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 vaccine in this patient cannot be completely excluded.
11pm (7 hours after) patient was awoken by and experienced muscle spasms in right hand. This has never occurred before in the patient. This continued for over an hour before subsiding.
I had a change in my heartbeat. There is a very hard beat followed by several other beats and almost a pause. I have no severe pain. I was told that I have premature ventricular beats (PVCs). I was asked to stop using Sudafed. At that time it was recommended that I get a CAC score. My cardiac aorta was normal. No medications were prescribed. I still have the issue with my heart it's just not as prominent as it used to be. I have a follow up appointment with my doctor scheduled to make sure that everything is good.
Area itching and burning, red, raised area. Area warm to touch. Raised area spreading around arm. Instructed pt to ice area and take BENADRYL. If area worse call or return to clinic.
Pt recvd 3 doses of Engerix-B & was not immune when tested p/completion of series 18APR92;
patient developed hives to shoulder, face and scalp 10 minutes after receiving covid vaccine. Treated with Benadryl 50 mg by mouth.  Doctor in to examine patient.
Eye pain started day of vaccination 2/3/21. Floaters and blurry vision started evening of vaccination/next morning. Triggered an autoimmune disease called Birdshot Uveitis- diagnosed 2/8/21.
The patient had the sensation of difficulty swallowing after the first injection. The patient was given Benadryl 50mg liquid by mouth once with complete resolution of symptoms. VSS
Shortness of Breath; Temperature of 102F; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of Breath) and PYREXIA (Temperature of 102F) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of Breath) and PYREXIA (Temperature of 102F). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and SOMATROPIN for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of Breath) and PYREXIA (Temperature of 102F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
This spontaneous report as received from a pharmacist, via Sanofi, refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, strength, route of administration not reported). On an unknown date the patient experienced anaphylactic response and tongue swelled. The patient was ok. The emergency care (reported as 911) came and patent resolved. The patient did not need anything. The relatedness between events and ZOSTAVAX was not reported. Additional information has been requested.
patient did not complete the series. It has been 25 months since her initial dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 29-Sep-2022 Reporter's Comments: The pharmacist reported that the patient did not complete the series and it has been 25 months since her initial dose.  The reporter asked did the patient need to start the series over or just complete the original series. The reporter consent to follow-up was granted. The case was linked with case US2022140216, reported by same reporter for different patient. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2022140216:Same reporter
Pain at injection site.  Pain/numbness traveled down arm into hand.  Tightness in chest, difficulty breathing, general all over weakness, dizziness and pain in lower back.
fever, h/a, malaise, arthalgia, flank pain, poor appetitie; dysuria, sore throat, URI, abdo pain;
Patient is a 58 y.o. female patient of DO with history of COPD, hypertension, hyperlipidemia, hypothyroidism, diabetes presented to Hospital with shortness of breath.   COPD with acute exacerbation  Acute hypoxemic respiratory failure  Started on Solu-Medrol 40 every 8 IV, will discontinue and transition to  IV Dexamethasone - course completed IV Rocephin stopped 10/8/23- discharge home on  Azithromycin 500 mg oral daily x 5 days Albuterol inhaler Discontinue IV fluids Pain management Blood cultures negative Sputum culture- not collected Wean Oxygen as tolerated- currently 98% on room air   Leukocytosis- chronic Likely reactive to steroids WBC- 23.2->16.02>18.82>20.42 Afebrile   Covid-19 Virus Infection Date of onset of symptoms: 10/3/2023 Symptoms present on admission: Yes Date of covid positive test: 10/5/2023 Vaccination status: vaccinated 1 dose Imaging: Chest x-ray unremarkable  Oxygen requirements on admission: 2 L Current oxygen requirements: room air Medical therapy: steroids Remdesivir  Consultants following: ID Anticipated special isolation end date: 10/15/2023 Encourage prone position as tolerated   DISCHARGE SUMMARY    Admitted: 10/5/2023 Discharge Date: 10/12/23    PCP Handoff    Recommended Outpatient Testing: none   Results Pending At Discharge: none     Clinical Summary   Patient is a 58 y.o. female patient of DO with history of COPD, hypertension, hyperlipidemia, hypothyroidism, diabetes presented to Hospital with shortness of breath.   COPD with acute exacerbation  Acute hypoxemic respiratory failure  Started on Solu-Medrol 40 every 8 IV, will discontinue and transition to  IV Dexamethasone - course completed IV Rocephin stopped 10/8/23- discharge home on  Azithromycin 500 mg oral daily x 5 days Albuterol inhaler Discontinue IV fluids Pain management Blood cultures negative Sputum culture- not collected Wean Oxygen as tolerated- currently 98% on room air   Leukocytosis- chronic Likely reactive to steroids WBC- 23.2->16.02>18.82>20.42 Afebrile   Covid-19 Virus Infection Date of onset of symptoms: 10/3/2023 Symptoms present on admission: Yes Date of covid positive test: 10/5/2023 Vaccination status: vaccinated 1 dose Imaging: Chest x-ray unremarkable  Oxygen requirements on admission: 2 L Current oxygen requirements: room air Medical therapy: steroids Remdesivir  Consultants following: ID Anticipated special isolation end date: 10/15/2023 Encourage prone position as tolerated   Type 2 diabetes uncontrolled Last A1c 5.7 I will hold insulin 70/30 24 twice a day Start Lantus 20 units at bedtime, Humalog 8 units every meal plus sliding scale Hold Trulicity in the hospital Start Januvia 100 mg once daily instead Hold metformin   Hypertension Continue losartan Hold Lasix- continue at discharge   Hypothyroidism Continue levothyroxine   GERD Continue Protonix   Hyperlipidemia Continue Zetia   Neuropathy Continue gabapentin   Nicotine use disorder  Advised smoking cessation  Start nicotine patch
Second Pfizer injection yesterday Body aches, chills, temp 99.9, arm hurts and can't life high, right calf has hurt since the first shot
Information has been received from a female PH.D whose daughter was vaccinated with Varivax. The Ph.d reported that after her daughter developed chicken pox (see WAES0112USA01686), the Ph.D also developed a fever and malaise. After her daughter became sick, the Ph. D developed a chicken pox like reaction in her mouth and on her tongue. The Ph.D stated that she "normally" experienced  neuraligia, and not a rash. She indicated that her physician "couldn't figure anything out". No further information is available.
a 13 week pregnant patient who received the first shot of the vaccine; lymphadenopathy; This is a spontaneous report from a contactable Physician via medical information team. A 13-week pregnant female patient of an unspecified age received first shot of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date at single dose, for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. Reporter was asking for any recommendations regarding the 2nd dose for a 13-week pregnant patient who received the first shot of the vaccine and developed lymphadenopathy a week after the 1st dose. She told that her gynecologist allowed her and gave her a note to take the 1st dose. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
inflammatory reaction on face; rashes; This spontaneous case was reported by a nurse and describes the occurrence of INFLAMMATION (inflammatory reaction on face) and RASH (rashes) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (inflammatory reaction on face) and RASH (rashes). The patient was treated with HYDROCORTISONE ongoing since an unknown date for Adverse event, at a dose of 1 dosage form. At the time of the report, INFLAMMATION (inflammatory reaction on face) and RASH (rashes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received first dose of Moderna Vaccine 3 weeks ago and scheduled to receive second dose. Patient is thinking on getting Pfizer BioNTech Covid-19 Vaccine instead of Moderna. HCP wanted to know how long patient should wait to restart vaccination series. No concomitants were reported.
An unidentified pt developed pain at the injection site, weakness and tingling subsequent to receiving an injection of Tetanus and Diphtheria Toxoids Adsorbed. Three weeks post vax, the pts symptoms reportedly persisted.
After taking the shot I had a very mild metallic taste in my tongue.   After about 45 minutes later the metallic taste became much stronger.  My lips felt like they were drying out, my tongue felt like it was swelling and drying out, and it felt difficult to swallow.  The strong sensation only lasted a couple of minutes.  It is now 7:48 PM and I still have a "very mild" case where my lips feel they are either itchy or mildly burning and my tongue still feels weird and has a very mild metallic taste.  I did not have any issues with tasting anything.  I also have a very mild headache.