chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treated for spontaneous pneumothorax on 04/26. Prior had recurrent right sided pneumothoraces (s/p talc pleurodesis 3/1/21 and blood patch pleurodesis 3/16/21). When discharged from hospital stay on 05/11, he left with pigtail chest tube still in place. Was still in place on 05/22 with difficulty breathing and pain.
I did not have an adverse reaction to the vaccine. I was exposed to COVID-19 while moving my son in 08/2022. I tested positive for COVID-19 in 08/2022. I isolated, rested, stayed hydrated and ate light meals. As of today, I do not have any lingering symptoms.
01/05 I notice some fatigue and coughing around 5pm and tried to shake off the mild symptoms as a light flu or cold. I found a place late the next day and got a Covid test at an urgent care facility on 01/07. The rapid test proved I had Covid. Was advised to quarantine and let it run its course. Loss of taste and smell occurred later 01/09 and had regained smell and taste about the 20th. Telehealth appointment with my PCP occurred on 13th and was advised quarantine lifted by 14th. Very mild intermittent cough persists but other than that and according to my PCP I am fully recovered as of 1/20.
11x5cm warm firm swelling @ inj site 24 hr p/vax; seen @ ER given Keflex & DPH;
On same day mother reports patient had an elevated indurated large circular erythematous lesion that was painful and firm.  Slight tactile fever.  Pain slightly improved with Tylenol.
got breakthrough COVID after receiving the vaccine/covid 19; This spontaneous case was reported by a patient and describes the occurrence of BREAKTHROUGH COVID-19 (got breakthrough COVID after receiving the vaccine/covid 19) in a 65-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030368) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    Patient had no allergy, concomitant diseases and risk factor. COVID-19 history reported as none.  Previously administered products included for COVID-19 prophylaxis: Moderna Covid-19 vaccine (Dose 1, Lot # 045A21A) on 24-Mar-2021, Moderna Covid-19 vaccine (Dose 2, Lot # 002C21A) on 21-Apr-2021, Moderna Covid-19 vaccine (Dose 3, Lot # 058H21A) on 06-Jan-2022, MODERNA COVID-19 VACCINE (Dose 4, Lot # 004M21A) on 07-May-2022, MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) (Dose 5 and Lot # 059F22A) on 18-Nov-2022. Past adverse reactions to the above products included No adverse reaction with MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5), Moderna Covid-19 vaccine, Moderna Covid-19 vaccine and Moderna Covid-19 vaccine.   In September 2023, the patient received dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 16-Sep-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 01-Oct-2023, the patient experienced BREAKTHROUGH COVID-19 (got breakthrough COVID after receiving the vaccine/covid 19). At the time of the report, BREAKTHROUGH COVID-19 (got breakthrough COVID after receiving the vaccine/covid 19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Oct-2023, SARS-CoV-2 test: Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  Reported that patient received flu shot a week after Spikevax 2023-2024.   This case was linked to US-MODERNATX, INC.-MOD-2023-745332 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2023: Live significant follow up received. Reference numbers added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745332:husband case
Information has been received from a registered nurse concerning a 66 years old female who on 19-DEC-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) rather than zoster vaccine live (Oka/Merck). No product confusion, just administration error. No problems reported. No other information was reported. There was no product quality complaint. Follow-up information received from a registered nurse indicated that there was no adverse event reported. Product confusion was reported because the nurse administered the wrong varicella virus vaccine. The vaccines are now kept in separate freezers. The nurse stated that there was no other information to report. No additional information is expected.
This spontaneous report as received from a registered nurse referring to an unspecified number of patients unknown age and gender. Pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, the patients were vaccinated with (Oka/Merck) VARIVAX, (dose, frequency and route of administration were not provided). The reporter stated that (Oka/Merck) VARIVAX, lot # reported as 000375 and expiration date 04-FEB-2017 was exposed in June 2015 and (Oka/Merck) VARIVAX lot # L012036 and expiration date 07-APR-2017 was exposed in August 2015, based in office records. No adverse effects were reported. Additional information has been requested.
On 6/28/07 received DTaP, IPV, MMR woke up 6/29/07 with right arm red and tender. Seen in our office diagnosed with early cellulitis due to immunization reaction. Prescribed Keflex.
Extreme migraine nausea vomiting dizziness disoriented vertigo symptoms lasted for two weeks
vertigo; threw up; dizzy; This case was reported by a consumer via call center representative and described the occurrence of vertigo in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th September 2019, the patient received the 1st dose of Shingrix. On 17th September 2019, less than a day after receiving Shingrix, the patient experienced vertigo, vomiting and dizziness. On an unknown date, the outcome of the vertigo, vomiting and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the vertigo, vomiting and dizziness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by patient's sister. The patient had the first dose of Shingrix and the same day vertigo, threw up and was dizzy.  Till the time of reporting the patient was experiencing the events. Reporter did not want to share any personal information.
Numbness and Pain on left side of face.  15 minutes after vaccine was given .  Not true bell palsy
Immediately after injection I felt my ears ringing and incredibly dizzy.  I felt as though my heart rate dropped really low and as if I might pass out.  The next day I experienced near black outs multiple times upon waking and had to be asleep all day. Because of the severe fatigue.  The following day since I still felt strange I went to the emergency room.  The symptoms of palpitations, scratchy throat, weakness, dizziness and confusion seems to wax and wane.  I also had pupils that were two different sizes when in the emergency room that day.  4 days after my first emergency room visit my itching throat symptoms got worse and I woke up feeling as though my throat was closing and I couldn?t breathe.  I was coughing and gagging and felt as though I was going to throw up.  I called my primary care doctor and they advised me to go to the hospital.  I returned again to the same hospital and the doctor confirmed it sounded like an additional allergic reaction to the vaccine.  I left the hospital yesterday 10/15/2021 and today I feel like I cannot move my neck, my throat appears to have closed more and I have severe tenderness and swelling around my neck, throat, and even jaw and face area.  I am truly concerned.  My follow up Dr appointment is on Tuesday 10/19/2021 and it was the earliest I could be seen.
SORENESS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age.. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. Batch number was not reported has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of soreness was not reported. This report was non-serious.
Local erythema, induration, tenderness. Swelling approximately equal to 10x15cm oval, 1 central 3mm papule. Noted 10 minutes after vaccine, seen in office 48 hours post vaccination.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 29Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in right 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. Concomitant medication(s) included: LISINOPRIL. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive. Therapeutic measures were taken as a result of covid-19.  Additional information: report about covid treatment was Yes. if vaccine received reported as Yes. other medication in 2weeks reported as Yes. anti viral details product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 03May2022, treatment stop date: 08May2022, indication: Treatment of COVID-19. other medication details: other medication in 2weeks product: Lisinopril. Five days after ending Paxlovid treatment, rapid tested positive for Covid. No symptoms at all since the first two days of originally testing positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a physician concerning a 5 month old pt with wheezing prior to immunization who in approx. 8/99 was vaccinated with a dose of haemophilus b conjugate vaccine (+) Hep-B vaccine recombinant (yeast). This report was part of a post-marketing surveillance program. Concomitant therapy included MMRII and diphtheria toxoid/pertussis vaccine/teta. The physician reported that the pt's wheezing got progressively worse over the 4 days, post vax. On 4/27/99, the pt was treated in the ER. The pt responded to bronchodilators. On 8/28/99, the pt's condition worsened and needed to be hospitalized. It was reported that the pt recovered. The reporting physician felt that the wheezing was possibly related to study therapy. No further information is available.
Narrative: Patient presented to ED on 1/8/2023 with chief complaint of upper respiratory symptoms for 2-3 days. Patient was admitted and placed in observation for mild acute hypoxemic respiratory failure secondary to acute COVID19 infection in setting of multiple sick contacts. She was on room air during evaluation. Treated with PRN nebulizers, IV steroids, vitamin C, and vitamin D.
2 weeks after vaccination, observed large muscle-shaped bulge around injection site. Painful like a damaged muscle or tendon would be, but not extreme. No heat, redness, or lymph swelling under arm. Used cold compresses and ibuprofen. Pain mostly disappeared over a week, but bulge, though smaller, is still present!  Late and long-lasting for ?Moderna arm? but fits the description. Over this tome I also developed a severe  vaginal yeast infection (haven?t had one for perhaps 10 years). Treated and mostly resolved.
HEART PROBLEM; ALLERGY FROM JANSSEN VACCINE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced heart problem and allergy from janssen vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart problem and allergy from janssen vaccine was not reported. This report was non-serious.
DTaP given on 7/28/03: left arm upper red, swollen 7"x5".
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date the patient was inadvertently administered a dose of PROQUAD (lot#, strength, dosage and route unknown) and a dose of MMR II (lot#, strength, dosage and route unknown) during the same office visit. No adverse effects reported. The outcome of the events was unknown. It was unspecified if the patient sought any medical attention. Additional information has been requested.
sleepiness; Woke up during the night with chills; severe arm aching & tenderness at injection site.; severe fatigue; anorexia; Missed work the next day due to HA; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Dec2020 at 09:30 (Lot number: EH9899) at the age of 63 years as dose 1, single for covid-19 immunisation at hospital. Relevant medical history included: "Polycythaemia vera", start date: 2020 (ongoing), notes: other medical history: Polycythaemia vera, Illness/AE: Polycythemia vera, Onset Date: 2020, Stop Date (check box if ongoing): ongoing; "Allergy to penicillin" (unspecified if ongoing), notes: Known allergy: PCN; "Asthma", start date: 2019 (ongoing), notes: Illness/AE: Asthma , Onset Date: 2019, Stop Date (check box if ongoing): ongoing; "allergies" (ongoing); "depression" (ongoing); "rhinorrhea" (ongoing); "Anemia" (ongoing); "bld thinner" (ongoing). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Vaccine was not administered at Military Facility. Concomitant medication(s) included: HYDREA taken for polycythaemia vera, start date: Oct2020 (ongoing); VIT D3; CALCIUM W VIT D; IRON taken for anaemia, start date: 2015 (ongoing); ASA taken for anticoagulant therapy, start date: 2019 (ongoing); EFFEXOR; SINGULAIR taken for asthma, start date: 2020 (ongoing); SIMICORT; AZELASTINE; SYMBICORT taken for asthma, start date: 2019 (ongoing); VENLAFAXINE taken for depression, start date: 2010 (ongoing); AZELASTINE HCL taken for hypersensitivity, start date: 2019 (ongoing); IPRATROPIUM taken for rhinorrhoea, start date: 2019 (ongoing); NASONEX taken for hypersensitivity, start date: 2019. Past drug history included: Codeine, reaction(s): "Allergy: Codeine", notes: Known allergy: Codeine.  The following information was reported: SOMNOLENCE (non-serious) with on-set 29Sep2021, outcome "recovered" (2021), described as "sleepiness"; CHILLS (non-serious) with onset 29Sep2021, outcome "recovered" (2021), described as "Woke up during the night with chills"; VACCINATION SITE PAIN (non-serious) with onset 29Sep2021, outcome "recovered" (2021), described as "severe arm aching & tenderness at injection site."; FATIGUE (non-serious) with onset 29Sep2021, outcome "recovered" (2021), described as "severe fatigue"; DECREASED APPETITE (non-serious) with onset 29Sep2021, outcome "recovered" (2021), described as "anorexia"; HEADACHE (non-serious) with onset 29Sep2021, outcome "recovered" (2021), described as "Missed work the next day due to HA".  Follow-up attempts are completed. No further information is expected.
68 y/o F with PMH uterine leiomyoma, radial styloid tenosynovitis, pain in limb, sprained ligament, diabetes, essential HTN, thyroid disease still which long-standing, vague, intermittent  RDQ discomfort. Received flu shot and PREVNAR in left deltoid on 9/14/15. Patient experienced itching in upper arm that night, next day a rash developed which has grown over the past week but stable in past 3 days. Itchy, mild to moderate. Not painful, Not having fevers, at work, feels fine otherwise. No other trauma or irritation to the area noted by the patient. The rash is below the site of injection. Per outpatient follow-up note 9/21 no distress, temp 98.2, HR 72, (L) arm erythematous, macular rash of 8 cm with mild warmth, not tender or indurated full ROM in arm in all directions. Infection unlikely in s/o (-) fever. Patient advised to take CLARITIN, ZYRTEC, or BENADRYL for the itch and to contact if any fever, if rash spreads further or if patient feels unwell. No rash noted per outpatient physical exam on 10/8.
Started having aches and pain at 11:00am on April 10th and by 2:00 pm i was running a fever of 100.4.  The by 6pm i was running a fever of 101.2 until 10:30 pm.  Fever finally broke around midnight.  Did not sleep because of the headache and aches and pains which lasted all day Sunday the 11th.  I did sleep better Sunday night and woke up felling better this morning.  Lungs are still not feeling the best.  I did take ibuprofen periodically during the time I was feeling bad.
The Sunday after I received the first dose, I noticed several hives on my back and stomach area when I woke up. I thought they were bug bites because they were so itchy. I applied Cortizone ointment and most of them stopped itching but remained. Before I went to bed, I noticed that they multiplied and had larger patches across my shoulder, upper back, chest and stomach area. I took a cold shower and applied more ointment. During the night, I couldn't sleep as it kept getting hot and itchy. When I woke up, the areas infected grew in size. The third morning (Tuesday 11/2) this happened, half of my back was covered, and the hives had spread down to my legs.  I continued to take my Zyrtec to help but the itching, redness, swelling common of hives still occurred. I still have it as of today. I contacted my doctor on 11/1 to let her know about it.
For 7 days: Severe flu-like symptoms that affected ADLs. Extreme pain and swelling in the upper arm shoulder and neck.
Rash at injection site then spread to bilateral torso, bilateral forearms, spots on hands and ankles.
sudden onset cardiomyopathy with EF 22% congestive heart failure in patient iwht no cardiac disease. normal cath, MRI showed myocarditis
Pustular rash clustered on back of legs, dorsally on both feet, toes, arms, and back. Required dermatology consult and course of oral steroids (Prednisone).
A non-serious spontaneous report of "29 patients received expired FLUMIST" was received form a physician concerning a seven-year-old female. The patients' medical history included no history of asthma. Concomitant medications were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Sine the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications). There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events with the medication error.
Woozy; Very dehydrated; Craving carbs; Felt like head was spinning; Felt like the patient was at high altitude for two days; Extremely tired; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the arm left on 31Mar2021 at 13:15(at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, migraine, hashimotos disease, factor v leiden mutation and allergy to large of chemicals (contact dermatitis). Concomitant medications included levothyroxine sodium (SYNTHROID), valaciclovir hydrochloride (VALTREX), cetirizine hydrochloride (ZYRTEC) and gabapentin (MANUFACTURER UNKNOWN) all from unknown date taken for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 13:15, the patient felt like she was at high altitude for two days (felt fine by 02Apr2021 Friday morning), woozy, very dehydrated, craving carbs and extremely tired. The wooziness hit within 5 min of getting the shot. The patient felt like head was spinning the whole drive home. The patient did not receive any treatment for the events. Events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events extremely tired(fatigue), woozy(Dizziness), very dehydrated(dehydration), craving carbs(food craving) and felt like head was spinning(vertigo)was recovered on an unknown date in 2021. The clinical outcome of the event felt like the patient was at high altitude(hypobarism) for two days was recovered on 02Apr2021.   No follow-up attempts are needed. No further information is expected.
04/15/2022 Vaccination 06/27/2022 I thought I had a fever, sore throat. I took some aspirin. Sweated during the night. I went to the airport. Felt like I was getting a cold.  06/28/2022 COVID-19 POSITIVE.  Prescribed Plaxovid.  I still have some drainage, coughing, sneezing but it seems to be diminishing. I am taking power naps. I have been feeling better since 07/05/2022. I do continue to have night sweats but seem to be subsiding.
Pain, tingling, numbness in opposite arm from vaccination. Persistent pain and weakness for over a week (still there).  Unable to do some normal things with my arm and hand. Lifting and range of motion is suddenly difficult. I had injured this arm and hand some years ago, but it had recovered and been fine for over four years.  This came on quite suddenly for no apparent reason (no abnormal use of arm or strain).  The only thing I can think that happened around the same time was the vaccination.