chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Positive for monkeypox after second dose of Jynneos vaccine; the infection occurred after the full course of two vaccinations.; Case reference number US-BN-2022-004303 is a spontaneous case report initially received on 21-Oct-22 from other health care professional via Bavarian Nordic (reference: BN_2022_02602) and concerns patient of unknown age and gender.  The patient's medical history and concomitant medications details were not provided.  On unspecified date, the patient was vaccinated with the first dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) at an unknown dose, through unknown route of administration, at unknown anatomical location, for unknown indication.  On unspecified date, the patient was vaccinated with the second dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) at an unknown dose, through unknown route of administration, at unknown anatomical location, for unknown indication.  On unspecified date, the patient was tested positive for monkeypox, as reported after the second dose of Jynneos.  At the time of this report, it was unknown rather there was treatment given to the patient due to any adverse event.  The Reporter did not assess the event per seriousness criteria and did not provide causality assessment to Jynneos.  Additional information received on 27-Oct-2022 from Bavarian Nordic included confirmation of the date when the request was made.; Reporter's Comments: A patient of unknown demographics was vaccinated with two doses of Jynneos, applied on unknown dates, via unknown anatomical sites or routes of administration. On an unknown date after the second dose, the patient tested positive for monkeypox (serious, medically significant event), which is considered as drug ineffective. The outcome of the event was unknown. Monkeypox is unlisted per the CCDS V1 and USPI for Jynneos. Drug ineffective is considered as listed per company convention. The patient's medical history and concomitant medications details were not provided. Considering that Jynneos is a non-replicating vaccine which does not contain the monkeypox virus, the event is assessed as not related to Jynneos. Drug ineffective has been considered as related to the suspect vaccine.; Sender's Comments: A patient of unknown demographics was vaccinated with two doses of Jynneos, applied on unknown dates, via unknown anatomical sites or routes of administration. On an unknown date after the second dose, the patient tested positive for monkeypox (serious, medically significant event), which is considered as drug ineffective. The outcome of the event was unknown. Monkeypox is unlisted per the CCDS V1 and USPI for Jynneos. Drug ineffective is considered as listed per company convention. The patient's medical history and concomitant medications details were not provided. Considering that Jynneos is a non-replicating vaccine which does not contain the monkeypox virus, the event is assessed as not related to Jynneos. Drug ineffective has been considered as related to the suspect vaccine.
7x7cm lt upper arm-erythematous raised lesion (hive) mildly warm to touch;
From Both Vaccines 1 and 2, I had headaches, nausea, brain fog, and ExTREME fatigue that lasted 4 weeks However  The extreme fatigue has never gone away - it's been 4 months. ALSO  after the vaccine, my Hashimoto's antibodies went up extremely high, my TSH went out of range, My blood sugar went crazy high, my cholesterol went high- It's as if my entire body went into a state of shock and inflammation. I had to increase my Thyroid medications, HOWEVER- I am still suffering from extreme fatigue. Its horrible and it has affected my life and work!
arm stiffness; redness; flushing; itchiness on her chest area; some joint pain; charley horse in her left foot; This is a spontaneous report from a non-contactable consumer. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 26Feb2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization.  The patient medical history was not reported. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; atorvastatin (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported.  The patient previously took amlodipine (MANUFACTURER UNKNOWN) and experienced flushing from an unspecified date to an unspecified date, contrast dye (MANUFACTURER UNKNOWN) and experienced mild reaction in 2009. On an unspecified date, the patient experienced arm stiffness (non-serious). On 28Feb2021, the patient experienced: some joint pain (non-serious), Charley horse in her left foot (non-serious). On 04Mar2021, the patient experienced: redness (non-serious), flushing (non-serious), and itchiness on her chest area (non-serious).  The patient had received her first Pfizer COVID vaccine on the 26Feb2021.  The patient was scheduled to receive her second vaccine dose on 19Mar2021 and wanted to find out if Pfizer would recommend for her to get this second dose.  After the first vaccination, the patient had a little arm stiffness that went away on its own with no treatment.  On 28Feb2021, following the first vaccine, the patient also had some joint pain and a Charley horse in her left foot. On 04Mar2021, 6 days after receiving the vaccine, the patient had some redness, flushing and itchiness on her chest area which also had resolved.  The patient would occasionally experience flushing due to the amlodipine 5mg (MANUFACTURER UNKNOWN) she takes. About 12 years ago, she had a test done and received IV contrast dye (MANUFACTURER UNKNOWN) and experienced a mild reaction to this and was treated with diphenhydramine hydrochloride (BENADRYL) and the reaction resolved.  The patient also took low dose of atorvastatin (MANUFACTURER UNKNOWN). Therapeutic measures were not taken as a result of arm stiffness; and not reported for the other events. The clinical outcome of the events: musculoskeletal stiffness, erythema, flushing, pruritus was recovered on an unspecified date. The clinical outcome of the event, arthralgia, muscle spasms was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.
707PNM pt devel a rash last few hr spread to arms & trunk;active & alert crying intermittently, redness around inj site rt thigh;dx allergic rxn to DTP inj;
Patient got COVID after getting the vaccine; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient got COVID after getting the vaccine) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AFF166B) for COVID-19 prophylaxis.   No Medical History information was reported.    On 05-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced COVID-19 (Patient got COVID after getting the vaccine). At the time of the report, COVID-19 (Patient got COVID after getting the vaccine) had resolved.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient had first shot were in //2021 and had every booster. Patient had small cough, mild cold and mild fever temperature.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-717380 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717380:Husband case
Pt is taking Etanercept (Immunosuppressing med) for psoriatic arthritis but was vaccinated by medic yesterday with Typhoid. PA was not aware of this patient as he was seeing patients during sickcall. Pt presented today with sore left shoulder and decreased ROM but no infection observed today only. Pt has hot compress and quarters. Pt doing well otherwise with stable vitals.
Headache, Myalgia, Fever, chills Narrative:  fever 102
Cold chills the first night and then achy flu feeling and so so sleepy even now 7 days later still feeling very bad
Pt had red swollen upper L arm with bruising in the center of the red area, fever, low grade x 3 days controlled with TYLENOL.
Tiredness, soar at vaccine site, mild soarness/pain at lower back (like when sick). Duration 4-6 hours.
patient given the flumist.  No symptoms.  Patient called to return to clinic to receive the flu injection.
5 other patients who experienced tinnitus after receiving a Covid-19 vaccine; 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 TINNITUS (5 other patients who experienced tinnitus after receiving a Covid-19 vaccine) 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 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 TINNITUS (5 other patients who experienced tinnitus after receiving a Covid-19 vaccine). At the time of the report, TINNITUS (5 other patients who experienced tinnitus after receiving a Covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
19 y/o patient, first time receiving flu vaccine. Right after shot was administered (3 minutes), patient experienced heavy tongue, forcibly closed eye and heavy arm. Then, 5 minutes after the patient experienced nausea.  Benadryl 25mg tablet was given to the patient. Patient was relatively stable while waiting for medical assistance.
A few weeks after the vaccine, I noticed a rash on my right lower back/side that was diagnosed as shingles at urgent care later that night. I was prescribed Valtrex, which I took for 7 days (3 times a day). Luckily, I caught the virus early enough that I did not have much pain. I had some itching once the rash was scabbing over. I also had a pins & needles feeling in my feet and right hand in the weeks leading up to my shingles diagnosis. I also had severe chills a few days before the shingles rash appeared.
Pain, burning, weakness, couldn't lift left arm or lay down (slept sitting up for 3 months). 2 Cortisone shots, 1 platelets injection, pain meds. and anti-inflammatory meds and therapy and HYDROGENIE. Still have problem dressing, sleeping, and carrying or lifting more than 5 lbs.
Fever Tmax 101 x 2 days. Shaking (L) leg 30 sec to 1 minute associated with not being interactive x 1 days but leg shaking lasted x 1 month per mother. Seen at ER.
Right upper thigh 13cm x 13cm redness, no evidence of warmth, sores are soft, neuro muscular, sensory, vascular intact, decrease fever and x 1 day. Treated with Rocephin IM and Keflex oral.
Soreness in left arm; Injection site feels hot to touch; Developed a small lump at injection site (left arm); More soreness in left arm; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in left arm), VACCINATION SITE WARMTH (Injection site feels hot to touch), VACCINATION SITE MASS (Developed a small lump at injection site (left arm)), VACCINATION SITE PAIN (More soreness in left arm) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in left arm), VACCINATION SITE WARMTH (Injection site feels hot to touch), VACCINATION SITE MASS (Developed a small lump at injection site (left arm)), VACCINATION SITE PAIN (More soreness in left arm) and VACCINATION SITE ERYTHEMA (Redness at injection site). On 06-Apr-2021, PAIN IN EXTREMITY (Soreness in left arm) had resolved. On 13-Apr-2021, VACCINATION SITE PAIN (More soreness in left arm) had resolved. At the time of the report, VACCINATION SITE WARMTH (Injection site feels hot to touch), VACCINATION SITE MASS (Developed a small lump at injection site (left arm)) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       relevant concomitant products usage were not reported by the reporter. Treatment details not included.
A few hours after getting the 2nd dose, I had the following reactions (I didn't go to the doctor, I'm just reporting what I experienced): *Slight rash consisting of pen-dot sized raised blisters which only appeared on top of a long-healed tattoo I have *Pain all throughout my right jugular (neck) *Sharp pain behind my right ear *Sleepiness *Dizziness *Muscle aches and muscle cramps  Most of these lasted less than 24 hours, but the tattoo rash was progressively becoming worse, I managed to get it under control on day 4 by applying hydrocortisone directly over the immidiate area. I still see a few bumps, but it seems to be healing. I didn't do anything differently in my daily routine; nothing changed (ie: same soap, same detergent, no contact with dust or etcetera). The tattoo also contains phosphorus, which might be related to the reaction.  The muscle aches and cramps are still ongoing; which is weird considering how I never get either and my daily activities haven't changed.
Patient was mistakenly given the HPV Vaccine instead of the Hepatitis A vaccine he was scheduled to receive.
her arm really bothered her/it hurt for a long time; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 74-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm really bothered her/it hurt for a long time".  Additional information: Caller states she had her Second Booster Dose on 5Apr2022 and that day it was a small dime size, red area with no pain, it just felt prickly. She states the following day it got larger and larger and it was red and hot and inflamed and that continued for about a week and then it didn't get any larger and the swelling started to go down but it was never sore, it was just achy, hot and inflamed. She states about a week later, the swelling started to subside and it was red until a couple of days ago. She states now it is just a dark bruised looking area and it is peeling and still achy and it is kind of hot and prickly feeling and really itchy. She states her symptoms are still present but much better She states she doesn't know what is going on and it was warm this morning but it is no longer warm now, but it is pricking and itching like crazy and peeling. She states she went to her Pharmacist today and he said he thought she should call Pfizer and notify of the reaction. She states the Pharmacist said she could put some steroid cream on it, but she hasn't. She states she had a Sore Arm after all of the first 3 Covid Vaccines. She had no fever, no ache, no headache. Call handler asked caller for dates and she responded with each of those vaccines.  She states she is just concerned if it is recommended she gets another booster, should she get it in the same arm if it is still bothering her this long after? She states it is not serious, she is just going to manage it as long as her arm doesn't start to slough off. Caller states she will go to the doctor if it gets worse.  There was no additional vaccines administered on same date of the Pfizer suspect. Adverse events did not require a visit to emergency room or physician office. No vaccinations were taken within 4 weeks prior to COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a nurse concerning a female who on 24-APR-2008 was vaccinated with a dose of GARDASIL (number of dose and lot number not reported). Concomitant therapy included PEDVAXHIB and MENACTRA (lot numbers not reported). On 24-APR-2008 the patient fainted after receiving GARDASIL. Subsequently, the patient recovered from fainting on an unspecified date. The patient sought unspecified medical attention. Additional information has been requested.
have all had break-thru cases; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (have all had break-thru cases) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 INFECTION (have all had break-thru cases). At the time of the report, INFECTION (have all had break-thru cases) outcome was unknown. Not Provided          Relevant concomitant medications were not reported.  The treatment information was  not provided.
Patient presented with abdominal pain that started after receiving his COVID vaccine and was found to have acute appendicitis
Headaches, dizziness, fatigue, injection site pain  starting approximately 10 hrs after injection and lasting an additional 24 hours
Pt's mother reports pt woke up in middle of the night after receiving vaccine with dizziness, sweats, nausea, and headache. Pt was seen in ER re: sx. CT scan of head negative. ER physician reports to mother that he believes sx are related to vaccine d/t unable to rule out any other causes at this time. Pt's mother reports patient had dizzy spells after first Bexsero vaccine on 6/30/2021 but states sx more severe this time.
This 63-year-old gentleman was admitted on 08/07/2022.  He has been noted to have a left upper lobe lung mass which is suspicious for carcinoma.  Evaluation is ongoing.  The patient describes a 2-week history of otalgia.  Initially, this involved the left ear, but later involved the right ear as well.  Pain is intermittent, moderate intensity, and may be triggered by opening his mouth wide.  He denies any  habit of clenching of teeth, but he has a lower denture which fits poorly.  He has had no otorrhea. He was kept on Ativan, Haldol and Thorazine for agitation.  He was certified by the psychiatrist.  Currently awaiting placement.  Incidentally, patient was noted to have swabbed positive for COVID-19.  He is currently admitted as psych facility will not take him till he is off COVID precautions.  He does not have any upper respiratory symptoms at this time.  No fevers or chills.  No chest pain or shortness of breath.  He mentions to have received 2 doses of the vaccine in 2021.  When I examined the patient, he did not want to go into details of why he was having homicidal and suicidal ideations. Pt medically cleared for discharged to Inpt Psych with Behavioral Center, with EMS transportation. Coordinated and arranged by Inpt psych. No other needs.
Information has been received from a medical assistant concerning a patient of unknown gender and age. There was no medical history or drug reactions/allergies reported. On unspecified days in March 2014 and July 2015, the patient was vaccinated with two doses of ZOSTAVAX (dose, route, lot number and expiration date were unspecified) (extra dose administered). No concomitant medication was reported. No adverse experience reported. There were no product complaints (PQC) involved. Additional information has been requested.
Breakthrough COVID infection. Patient fully vaccinated 3/10/21. Patient tested positive for COVID on 8/14/21.
she is experiencing mild body aches; I feel this a little bit achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset Nov2022, outcome "unknown", described as "she is experiencing mild body aches; I feel this a little bit achy".  Additional information: The patient stated she just got her COVID-19 vaccine Bivalent (Clarified as Pfizer COVID-19 Bivalent Vaccine) yesterday and she is experiencing mild body aches and she is asking if it is okay to take Advil. While confirming the name, Consumer stated, "I can't understand a thing you are saying, nothing. I just needed a simple question, can I take Tylenol (Later clarified as Advil) because I feel this a little bit achy but I will just wait and I will call the pharmacy when they open but thank you anyways."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
12:30 nauseated c/o being sick & belly hurting;1:00 rash over entire body;encouraged to go to ER for eval;
Case number PHEH2014US015571 is an initial spontaneous report received from a nurse on 30 Jul 2014. This report refers to an 11 year old female patient. Past medical history and concomitant medications was not reported. She received only Men A lyophilized conjugate component of MENVEO (batch number: M13051), intramuscularly reconstituted with a sterile diluent instead of MenCYW-135 liquid component on 29 Jul 2014. No adverse reaction reported following this administration error.